CClinicalTrials.gg
Status unknownNCT03804086Updated Jan 17, 2019

Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects

An interventional study of Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement and Open flap debridement in Periodontitis, sponsored by Hadeer Ashraf Hassan Roushdy. Status unknown. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Hadeer Ashraf Hassan Roushdy · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Sex
All
01

Study summary

this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects.

In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .

02

Conditions studied

  • Periodontitis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Patient-related criteria:

  • Systemically healthy patients.
  • Compliance with oral hygiene instructions and the maintenance program provided.
  • Accepts the 6 months follow-up period.
  • Provide informed consent.

Teeth related criteria:

  • Mature permanent tooth.
  • Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
  • Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
  • Presence of radiolucency in the furcation area on an intra-oral periapical radiograph

Exclusion criteria

Exclusion Criteria:

Patient-related criteria:

  • Patients taking drugs known to interfere with periodontal wound healing in the last six months.
  • Pregnant or nursing women.
  • Smokers.
  • Uncooperative patients.

Teeth related criteria:

  • Teeth with interproximal supra-bony or intrabony defects.
  • Teeth with gingival recession.
  • Teeth with grade II or III mobility.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Test Group

    Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).

    Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement

  • Active comparator
    Control Group

    Open flap debridement alone.

    Procedure: Open flap debridement

Interventions

  • ProcedureAdvanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement

    will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant. * The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature. * After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.

  • ProcedureOpen flap debridement

    a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.

05

What researchers measure

Primary outcomes

  1. Relative Vertical Clinical Attachment Level (RVCAL)

    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe

    Time frame: 6 months

Secondary outcomes

  1. Relative Horizontal Clinical Attachment Level (PHCAL)

    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe

    Time frame: 6 months

  2. Probing Depth (PD)

    Probing depth measured from the gingival margin to the base of the pocket.

    Time frame: 6 months

  3. Gingival margin Level (GML)

    • Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03804086
Lead sponsor
Hadeer Ashraf Hassan Roushdy
Responsible party
Hadeer Ashraf Hassan Roushdy (Dentist, Cairo University) — Sponsor-investigator
First posted
Jan 15, 2019
Start date
Feb 2019 (estimated)
Primary completion
Nov 2019 (estimated)
Completion
Feb 2020 (estimated)
Last update
Jan 17, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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